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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05483998
Registration number
NCT05483998
Ethics application status
Date submitted
27/07/2022
Date registered
2/08/2022
Date last updated
20/05/2024
Titles & IDs
Public title
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
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Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of TLC-2716 in Healthy Subjects
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Secondary ID [1]
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2716-CL-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TLC-2716
Other interventions - Placebo
Experimental: Part A: Single Ascending Dose (SAD) - Part A will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive a single oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level).
Experimental: Part B: Multiple Ascending Dose (MAD) - Part B will be comprised of up to 50 healthy participants over 5 cohorts of 10. Each participant will receive 14 oral doses of TLC-2716 or placebo over 14 days (given once daily) at different dose levels (1 cohort per dose level).
Experimental: Part C: Adaptive SAD and/or MAD - Part C is an adaptive style where the dosing level is a single- or multiple-ascending dose design. Based on safety and pharmacokinetic data from Parts A and B, doses for Part C will be chosen. Part C will be comprised of up to 50 participants over 5 cohorts of 10. Each participant will receive an oral dose of TLC-2716 or placebo at different dose levels (1 cohort per dose level).
Treatment: Drugs: TLC-2716
TLC-2716
Other interventions: Placebo
Placebo to match
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of subjects with treatment-emergent adverse events (TEAEs) in single ascending dose (SAD) compared to placebo
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Assessment method [1]
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TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
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Timepoint [1]
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Up to Day 15
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Primary outcome [2]
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Number of subjects with clinically significant change from Baseline in vital signs in SAD
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Assessment method [2]
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Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
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Timepoint [2]
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Day 1-Day 4, and Follow-up (after 11 days)
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Primary outcome [3]
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Number of subjects with laboratory abnormalities in SAD
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Assessment method [3]
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Hematology and serum chemistry.
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Timepoint [3]
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Up to 15 days
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Primary outcome [4]
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Number of subjects with electrocardiogram (ECG) abnormalities in SAD
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Assessment method [4]
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12-lead ECG.
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Timepoint [4]
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Up to 15 days
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Primary outcome [5]
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Number of subjects with TEAEs in multiple ascending dose (MAD) compared to placebo
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Assessment method [5]
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TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.
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Timepoint [5]
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Up to Day 28
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Primary outcome [6]
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Number of subjects with clinically significant change from Baseline in vital signs in MAD
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Assessment method [6]
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Vital signs include blood pressure, heart rate, respiratory rate, and temperature.
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Timepoint [6]
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Day 1 - Day 3, Day 5, Day 7, Day 10, Day 14, Day 17, and Follow-up (after 11 days)
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Primary outcome [7]
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Number of subjects with laboratory abnormalities in MAD
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Assessment method [7]
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Hematology and serum chemistry.
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Timepoint [7]
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Up to 28 days
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Primary outcome [8]
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Number of subjects with ECG abnormalities in MAD
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Assessment method [8]
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12-lead ECG
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Timepoint [8]
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Up to 28 days
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Secondary outcome [1]
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Plasma concentration of each dose of study drug to determine AUClast in SAD
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Assessment method [1]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [1]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [2]
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Plasma concentration of each dose of study drug to determine AUCinf in SAD
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Assessment method [2]
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AUCinf is defined as the concentration of drug extrapolated to infinite time.
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Timepoint [2]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [3]
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Plasma concentration of each dose of study drug to determine %AUCexp in SAD
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Assessment method [3]
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%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
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Timepoint [3]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [4]
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Plasma concentration of each dose of study drug to determine CL/F in SAD
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Assessment method [4]
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CL/F is defined as the apparent oral clearance following administration of the drug.
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Timepoint [4]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [5]
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Plasma concentration of each dose of study drug to determine Cmax in SAD
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Assessment method [5]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [5]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [6]
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Plasma concentration of each dose of study drug to determine Tmax in SAD
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Assessment method [6]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [6]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [7]
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Plasma concentration of each dose of study drug to determine Clast in SAD
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Assessment method [7]
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Clast is defined as the last observable concentration of drug.
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Timepoint [7]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [8]
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Plasma concentration of each dose of study drug to determine Tlast in SAD
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Assessment method [8]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [8]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [9]
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Plasma concentration of each dose of study drug to determine t1/2 in SAD
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Assessment method [9]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [9]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [10]
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Plasma concentration of each dose of study drug to determine ?z in SAD
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Assessment method [10]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [10]
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Day 1: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 12, 24, 48, and 72 hours post-dose
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Secondary outcome [11]
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Plasma concentration of each dose of study drug to determine AUClast in MAD
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Assessment method [11]
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AUClast is defined as the concentration of drug from time zero to the last observable concentration.
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Timepoint [11]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [12]
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Plasma concentration of each dose of study drug to determine AUCtau in MAD
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Assessment method [12]
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AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
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Timepoint [12]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [13]
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Plasma concentration of each dose of study drug to determine Ctau in MAD
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Assessment method [13]
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Ctau is defined as the observed drug concentration at the end of the dosing interval.
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Timepoint [13]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [14]
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Plasma concentration of each dose of study drug to determine CLss/F in MAD
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Assessment method [14]
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CLss/F is the total body clearance for extravascular administration divided by the fraction of dose absorbed.
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Timepoint [14]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [15]
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Plasma concentration of each dose of study drug to determine Cmax in MAD
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Assessment method [15]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [15]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [16]
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Plasma concentration of each dose of study drug to determine Tmax in MAD
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Assessment method [16]
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Tmax is defined as the time (observed time point) of Cmax.
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Timepoint [16]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [17]
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Plasma concentration of each dose of study drug to determine Clast in MAD
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Assessment method [17]
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Clast is defined as the last observable concentration of drug.
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Timepoint [17]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [18]
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Plasma concentration of each dose of study drug to determine Tlast in MAD
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Assessment method [18]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [18]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [19]
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Plasma concentration of each dose of study drug to determine t1/2 in MAD
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Assessment method [19]
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t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [19]
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Day 1, Day 3, Day 7, Day 14
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Secondary outcome [20]
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Plasma concentration of each dose of study drug to determine ?z in MAD
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Assessment method [20]
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?z is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.
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Timepoint [20]
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Day 1, Day 3, Day 7, Day 14
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Eligibility
Key inclusion criteria
* Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive
* Body mass index from 19 to 35 kg/m2, inclusive
* Estimated glomerular filtration rate = 80 mL/min
* Normal liver biochemistry tests
* Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance
* Subject must have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator
* Females of childbearing potential must have a negative pregnancy test at Screening and clinic admission
* Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Pregnant or lactating subjects
* Subjects with triglycerides = 500 mg/dL
* Subjects with low-density lipoprotein = 190 mg/dL
* Subjects who have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with the subject's treatment, assessment, or compliance with the protocol
* Subjects who have received any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to study drug dosing
* Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
* Current substance abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
* A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen, or hepatitis C (HCV) antibody
* Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen (paracetamol), ibuprofen, and/or hormonal contraceptive medications
* Subjects who have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
* Medical history of serious skin disease in the opinion of the investigator, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
* Medical history of drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
* Presence or history of cardiovascular disease, including significant cardiovascular disease (including a history of myocardial infarction based on ECG and/or clinical history), history of cardiac conduction abnormalities (including any history of ventricular tachycardia), congestive heart failure, cardiomyopathy with left ventricular ejection fraction < 40%, a family history of Long QT Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
* Syncope, palpitations, or unexplained dizziness
* Implanted defibrillator or pacemaker
* Medical history of liver disease, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency)
* Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions
* History of medical or surgical treatment that permanently alters intestinal absorption (e.g., gastric or intestinal surgery)
* Subjects who have received vaccination for COVID-19 within 14 days of Admission
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/06/2023
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
OrsoBio, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
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Trial website
https://clinicaltrials.gov/study/NCT05483998
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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OrsoBio Study Director
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Address
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OrsoBio, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05483998
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